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临床试验/NCT03498768
NCT03498768Unknown不适用

Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity :a Prospective Multicentre Study

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Psychological status of patients with lung nodules

研究概览

简要总结

Lung cancer is one of the leading cause of cancer related death in China.Different from patients in the US, Chinese patients with lung nodules tend to be less related to smoking, and seem to be more willing to get operation despite of the doctors' suggestion of imaging surveillance.

This study is designed to figure out the risk factors for Chinese lung cancer patients and evaluate the psychosocial status of inpatients with lung nodules.

详细描述

Smoking is the only determinate risk factor proposed by the NCCN(National Comprehensive Cancer Network) Clinical Practice Guidelines for lung cancer screening. However, it has been estimated that over half of Chinese female lung cancer patients are non-smokers. Thus it might be reasonable to take unique Chinese cooking habit and environment pollution into consideration when it comes to the risk factors for lung cancer in Chinese people.

Lung nodules are reported to exist in 25-70% patients who have undergone LDCT (Low-dose Computed Tomography)examination. However, the prevalence of malignant nodules is reported to be 1.1-3% by different researchers. Even in country with comprehensive medical consulting system and lung nodule management consensus, almost all patients assume their lung nodules to be malignant when detected by LDCT for the first time.The investigators noticed nearly 1/3 of the inpatients are determined to get operation despite the surgeons' suggestion of CT surveillance according to the NCCN guideline in Department of Thoracic surgery in Peking University People's Hospital. As there's no evidence suggesting lung nodules in Chinese people have more possibility of malignancy, the investigators would like to know whether those patients who choose to get operation "ahead of the guideline" has higher level of cancer distress, and figure out whether psychosocial factors should be taken into consideration of lung nodules management when living with an indeterminate tumor has added up to patients' negative emotion and reduced their quality of life.

The investigators do the survey on the first day of admission during the inpatient education, help patients fill in the questionnaire including personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatients in Department of Thoracic Surgery in Peking University People's Hospital and Beijing Haidian Hospital.
  • Tolerant to surgery with accessible pathology outcome.
  • Aged between 18-
  • Signed Informed Consent Form.

排除标准

  • Patients who have difficulty in reading and writing.
  • Poor physical status without sufficient respiratory reserve to undergo surgery.
  • Unaccessible for surveillance after surgery.
  • Refuse to take part.
  • Other circumstances which is deemed inappropriate for enrollment by the researchers.

结局指标

主要结局

Psychological status of patients with lung nodules

时间窗: 1.5 years

Patients with lung nodules are invited to fill in the Hospital Anxiety and Depression Scale (HADS) during inpatient education. Patients are thus grouped depending on whether they have indication for biopsy or operation according to the NCCN guideline for lung nodules management. As a result, patients who accept surveillance long enough or have proper indication for operation are one group, patients who stop surveillance and choose to get operation "ahead of time" are the other group. The level of negative emotion would be analyzed and compared afterwards.

Risk factors for Chinese lung cancer patients

时间窗: 1.5 years

Patients with lung nodules are invited to fill in a questionnaire including personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, this procedure is finished during inpatient education before the operation. After the operation, we analyze the factors and patients' pathology results to figure out the risk factors for Chinese lung cancer patients.

次要结局

  • Life quality of patients with lung nodules(1.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Wang

Principal Investigator, Clinical Professor

Peking University People's Hospital

研究点 (1)

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